madman
Super Moderator
* Vildegra is a generic drug of Sildenafil, enclosed in Hypromellose shell. That ensures an active substance gradual release and a long-lasting effect of Vildegra in comparison to Viagra. The duration of Vildegra effect is up to 13 hours, Viagra – up to 4 hours.
Abstract
Introduction and Objective
Sildenafil citrate (Viagra) intake is associated with frequent side effects like headache or hemodynamic instability. Vildegra is a prolonged release drug form and such optimization of pharmacokinetics might reduce the frequency and manifestation of side effects. This study aimed at evaluating the efficacy of 4-week therapy with Vildegra, it’s safety and the manifestation of side effects in patients with ED in comparison to placebo and Viagra.
Methods
Vildegra is a generic drug of Sildenafil, enclosed in Hypromellose shell. That ensures an active substance gradual release and a long-lasting effect of Vildegra in comparison to Viagra. The duration of Vildegra effect is up to 13 hours, Viagra – up to 4 hours. Triple cross-randomized open-label placebo controlled clinical trial was conducted to study outcomes of treatment with the drug "Vildegra" 50 mg in comparison with the drug "Viagra" 50 mg. This clinical trial was conducted after IRB approval in accordance to the Protocol, World Medical Association Declaration of Helsinki and Tripartite guideline on Good Clinical Practice (ICH GCP).Patients: men aged 19 to 60 years with an established diagnosis of ED. The following methods were applied in the study: physical examination, ultrasound of penile blood flow during erection with Viagra, ECG, IIEF, IIEF-5, SEP, GAQ questionnaires, patient diary, laboratory methods. Patients in the experimental group were administered monotherapy in the following sequence: 28 days with Vildegra, a week-long wash-out period, 28 days of placebo, another one week wash-out period, and 28 days of Viagra. In the control group, the drug intake sequence was different: Viagra-placebo-Vildegra.
Results
60 patients were enrolled in this study. Vildegra increased sexual activity according to questionnaires and patient diaries 1.6 times higher than Viagra and 2.4 times higher than placebo.The frequency of adverse events during Vildegra therapy was 1.6 times lower comparing to Viagra. During the wash-out period after taking Sildenafil, the EF continued to improve, that indicates the after effect of Vildegra and Viagra. As a result of 28-day therapy with Vildegra the EF assessment on the IIEF-5 scale increased significantly by 49.3%, p<0.05 in comparison with placebo. For Vildegra vs Viagra baseline values were 14±3.8 and 13.9±3.5, respectively, and after 1 month 20.9±3 and 20±3.4, p=0.678. According to the questionnaires in 96.6% of patients the erection lasted long enough to have successful sexual intercourse with ejaculation.At the end of the study the ECG were without any clinically significant negative dynamics, Vildegra did not have any negative effect impact on laboratory analyses.
Conclusions
Vildegra in not inferior to Viagra in terms of efficacy while it is better tolerated by patients. That influenced the higher frequency of Vildegra intake compared to Viagra.
Abstract
Introduction and Objective
Sildenafil citrate (Viagra) intake is associated with frequent side effects like headache or hemodynamic instability. Vildegra is a prolonged release drug form and such optimization of pharmacokinetics might reduce the frequency and manifestation of side effects. This study aimed at evaluating the efficacy of 4-week therapy with Vildegra, it’s safety and the manifestation of side effects in patients with ED in comparison to placebo and Viagra.
Methods
Vildegra is a generic drug of Sildenafil, enclosed in Hypromellose shell. That ensures an active substance gradual release and a long-lasting effect of Vildegra in comparison to Viagra. The duration of Vildegra effect is up to 13 hours, Viagra – up to 4 hours. Triple cross-randomized open-label placebo controlled clinical trial was conducted to study outcomes of treatment with the drug "Vildegra" 50 mg in comparison with the drug "Viagra" 50 mg. This clinical trial was conducted after IRB approval in accordance to the Protocol, World Medical Association Declaration of Helsinki and Tripartite guideline on Good Clinical Practice (ICH GCP).Patients: men aged 19 to 60 years with an established diagnosis of ED. The following methods were applied in the study: physical examination, ultrasound of penile blood flow during erection with Viagra, ECG, IIEF, IIEF-5, SEP, GAQ questionnaires, patient diary, laboratory methods. Patients in the experimental group were administered monotherapy in the following sequence: 28 days with Vildegra, a week-long wash-out period, 28 days of placebo, another one week wash-out period, and 28 days of Viagra. In the control group, the drug intake sequence was different: Viagra-placebo-Vildegra.
Results
60 patients were enrolled in this study. Vildegra increased sexual activity according to questionnaires and patient diaries 1.6 times higher than Viagra and 2.4 times higher than placebo.The frequency of adverse events during Vildegra therapy was 1.6 times lower comparing to Viagra. During the wash-out period after taking Sildenafil, the EF continued to improve, that indicates the after effect of Vildegra and Viagra. As a result of 28-day therapy with Vildegra the EF assessment on the IIEF-5 scale increased significantly by 49.3%, p<0.05 in comparison with placebo. For Vildegra vs Viagra baseline values were 14±3.8 and 13.9±3.5, respectively, and after 1 month 20.9±3 and 20±3.4, p=0.678. According to the questionnaires in 96.6% of patients the erection lasted long enough to have successful sexual intercourse with ejaculation.At the end of the study the ECG were without any clinically significant negative dynamics, Vildegra did not have any negative effect impact on laboratory analyses.
Conclusions
Vildegra in not inferior to Viagra in terms of efficacy while it is better tolerated by patients. That influenced the higher frequency of Vildegra intake compared to Viagra.
